Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. Nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. Therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. A priori, the following hypotheses are formulated:

• A 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
• A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
• A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

Condition	Treatment or Intervention
Sarcoidosis	Behavior: High-intensity exercise training

Further Study Details: 

Primary Outcomes: Health status: Medical Outcomes Study 36-Item Short-Form Health Survey; Disease-specific quality of life: Sarcoidosis Health Questionnaire; Peak exercise capacity: a symptom-limited peak exercise test on a cycle ergometer; Functional exercise capacity (I): a symptom-limited endurance cycling test at 70% of the achieved peak external load; Functional exercise capacity (II): the distance walked in 6 minutes
Secondary Outcomes: Pulmonary function: forced vital capacity and transfer factor for carbon monoxide; Muscle function: isometric quadriceps femoris muscle peak torque; Systemic inflammation: circulating levels of IL-2, sIL-2r, IL-6, IL-8, TNF-alpha, sTNFR-p55, sTNFR-p75; Anxiety and depression: Hospital Anxiety and Depression Scale; Health-related quality of life (I): Chronic Respiratory Disease Questionnaire; Health-related quality of life (II): St. George's Respiratory Questionnaire
Expected Total Enrollment:  30

The EXTRAS study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)

Exclusion Criteria:

• A history of neurosarcoidosis
• Undergoing structured exercise training at the time of enrollment or in the preceding 6 months
• Current participation in a pharmacological study
• Cardiovascular abnormalities on the ECG during baseline peak exercise test
• A ‘normal’ baseline peak oxygen uptake (≥90% of the predicted values) in combination with a ‘normal’ quadriceps peak torque or distance walked in 6 minutes

Martijn A. Spruit, PhD      +32 16 34 71 08    maspruit@yahoo.com
Michiel J. Thomeer, MD      +32 16 34 68 04    michiel.thomeer@uz.kuleuven.ac.be

Belgium, Vlaams-Brabant
      University Hospital Leuven, Leuven,  Vlaams-Brabant,  B-3000,  Belgium; Recruiting

Study chairs or principal investigators

Martijn A. Spruit, PhD,  Principal Investigator,  Katholieke Universiteit Leuven   
Marc Decramer, PhD MD,  Study Director,  University Hospital Gasthuisberg   
Michiel J. Thomeer, MD,  Study Chair,  University Hospital Gasthuisberg   

Study ID Numbers:  ML2563
Record last reviewed:  December 2004
Last Updated:  December 13, 2004
Record first received:  December 13, 2004
ClinicalTrials.gov Identifier:  NCT00099424
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08